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Post Acute Coronary Event Smoking Study (PACES)

2017年1月10日 更新者：Andrew Busch、The Miriam Hospital

Integrated Smoking Cessation and Mood Management for Cardiac Patients

Smoking and depressed mood are both predictive of mortality following Acute Coronary Syndrome. However, to date, no counseling treatment has been designed to target smoking cessation and manage mood in this population. This trial will test such a treatment based on Behavioral Activation, an approach that has shown promise as an integrated treatment for smoking and mood management in other populations.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The occurrence of Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) can be conceptualized as a "teachable moment," whereby patients may be more receptive to smoking cessation messages. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS hospitalization. Thus, a single, integrated treatment that targets both depressed mood and smoking could be highly effective in reducing post-ACS mortality. Behavioral Activation (BA) may be an ideal treatment for this population as BA can easily integrate both mood and smoking cessation related goals and it focuses on addressing restriction of valued activities, which is common in the post-ACS population.

Thus, the overall aim of the current study is test a BA treatment manual that integrates smoking cessation and mood management for post-ACS smokers (Behavioral Activation Treatment for cardiac patients who smoke; BAT-CS). We will conduct an RCT (N=72) comparing BAT-CS (1 in-hospital session and 5-9 post-discharge sessions) to Standard Care (SC; 1 in-hospital session and 5 mailed packets of printed self-help materials). Differences in smoking cessation, depressed mood, and positive affect will be compared between conditions.

研究类型

介入性

注册 (实际的)

65

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • The Miriam Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • ACS diagnosis documented in medical record
  • smoked 3 or more cigarettes per day before being hospitalized
  • between the ages of 18-75
  • fluent in English
  • regular access to a telephone
  • lives in the Providence, RI area
  • willing to "strongly consider" an attempt to quit smoking at discharge

Exclusion criteria:

  • limited mental competency (i.e., Mini-Mental Status exam < 20)
  • presence of current psychosis, serious mental illness, or suicidality, expectation that patient will not live through 6 month study period
  • currently regularly attending counseling for depression or smoking cessation and plans to continue after discharge

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：BA for cardiac patients who smoke
Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
行为的：Behavioral Activation (BA)
5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
行为的：Standard Smoking Cessation Counseling
1 hour of in hospital counseling based on clinical guidelines
药品：Nicotine patch
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
有源比较器：Standard Care
Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
行为的：Standard Smoking Cessation Counseling
1 hour of in hospital counseling based on clinical guidelines
药品：Nicotine patch
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
其他：Printed Self-help materials for Smoking Cessation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Smoking Cessation: 7 Day Point Prevalence Abstinence
大体时间：6 months
No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
6 months
Continuous Abstinence From Smoking Since Discharge
大体时间：6 months
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
6 months
Time to Smoking Relapse
大体时间：6 months
Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
6 months
Time to Smoking Lapse
大体时间：6 months
Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
6 months

次要结果测量

结果测量
措施说明
大体时间
Depression: 9 Item Patient Health Questionnaire (PHQ-9)
大体时间：Baseline to 6 months
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Baseline to 6 months
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
大体时间：Baseline to 6 months
The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Baseline to 6 months
Positive Affect
大体时间：Baseline to 6 months
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance
Baseline to 6 months
Negative Affect
大体时间：Baseline to 6 months
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Baseline to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Miriam Hospital

调查人员

  • 首席研究员：Andrew M Busch, Ph.D、The Miriam Hospital Centers for Behavioral and Preventive Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年10月1日

初级完成 (实际的)

2015年4月1日

研究完成 (实际的)

2015年4月1日

研究注册日期

首次提交

2013年10月15日

首先提交符合 QC 标准的

2013年10月15日

首次发布 (估计)

2013年10月17日

研究记录更新

最后更新发布 (估计)

2017年1月12日

上次提交的符合 QC 标准的更新

2017年1月10日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 5K23HL107391 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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